Transapical access can be a desirable option for minimally invasive procedures in the heart, such as aortic valve reoperation, Mitral valve and annulus repair/replacement and reoperation, ablation of arrhythmia foci in cardiac chambers, Left atrial appendage closure, aortic endo-grafting for aneurysms, percutaneous coronary intervention, VSD closure, and ablative LA and LV procedures. The transapical access may provide improved device control with a shorter distance to the target site, less stored tension or slack in the delivery system, access to all left sided structures and aorta. This is in contrast to some transfemoral access disadvantages such as a longer distance to the target with possibly less control and stored tension and slack in the access system, and all left sided structures may not be accessible.
When the transapical access procedure is completed previous techniques that provides for closure of the access opening in the apex of the left ventricle includes drawing the surrounding tissue at the opening together by sutures or using more complex structures that applies tension to the tissue to be drawn together around the access hole.
A problem with prior art is local shear forces that may cause myocardial damage and tearing by such techniques. This may in particular occur if the transapical procedure requires a sheath of a larger dimension such as 18, 24 or 32 Fr, or larger, where the tissue around the resulting access opening needs to be pulled together more to close the opening. This may also cause more bleeding and a lengthier procedure to control the bleeding, e.g. by additional suturing. Tearing, damage or rupture at the aortic root require subsequent repair and even a complete root replacement operation.
A further problem is the high level of precision and skill required using the previous closure techniques, that use a multitude of operational steps involving significantly complex steps, requiring more time, and/or with a potential risk of insufficient closure of the access site.
The above problems may have dire consequences for the patient and the health care system. Patient risk is increased.
Thus, there is a need for a closure solution which allows safe and easy closure of the transapical access opening with consistent and predictable results.
A compact closure device is also desirable for quick and easy delivery, for example via a catheter, and for occupying less space in the body, expose a minimum of foreign material to the surrounding anatomy and blood stream, and thereby reducing chance of interference with bodily functions.
Further, a degree of flexibility of a transapical access closure device to accommodate anatomical movements without fatigue or risk of loosening from the implantation site during an ingrowth period is also a desired characteristic of such device.
Hence, an improved device would be advantageous and in particular allowing for improved occlusion of transapical access openings, procedural effectiveness, and/or patient safety would be advantageous.